FDA product code MLV: Transcatheter Septal Occluder
MLV is the FDA product code for transcatheter septal occluder. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MLV reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 15 recalls for MLV devices, 2 initiated in the last five years.
Definition
Approved PMA: P000039
Classification
| Field | Value |
|---|---|
| Device name | Transcatheter Septal Occluder |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for MLV devices
15 product recalls in 5 recall events; 2 initiated in the last five years and 11 still open. Most recent: 2022-12-14.
| Year | Recalls |
|---|---|
| 2021 | 9 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code MLV?
MLV is the FDA product code for transcatheter septal occluder. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MLV?
Class III. Typical premarket route: PMA.
Have MLV devices been recalled?
Yes: 15 product recalls across 5 recall events; the most recent began 2022-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code MLV
- Run a recall and safety report across every MLV manufacturer
- Watch product code MLV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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